PALOMA-2 AEs

AEs (≥10%) From Any Cause Reported in PALOMA-2 (As-treated Population)¹

*One death secondary to lower respiratory tract infection and pulmonary embolism occurred in the placebo + letrozole group and was believed to be treatment related. 
^†Grade 4 events that were reported in the PALBACE^® + letrozole group but not shown in the table were increased ALT level, increased blood creatinine level, febrile neutropenia, pulmonary embolism, acute kidney injury, hyperuricaemia, acute pancreatitis, pathologic fracture, pericardial effusion, sepsis, increased amylase level, aortic valve stenosis, pulmonary oedema, staphylococcal bacteraemia, thrombotic cerebral infarction, urosepsis and increased lipase level; these Grade 4 events were reported in 1 patient each, except for increased lipase level, which was reported in 2 patients.
^‡Categorised according to the MedDRA PTs. Neutropenia: neutropenia and neutrophil count decreased; Leukopenia: leukopenia and white blood cell count decreased; Anaemia: anaemia, haematocrit decreased and haemoglobin decreased. Rash: dermatitis, dermatitis acneiform, rash, rash erythematous, rash maculopapular, rash papular, rash pruritic and toxic skin eruption; Thrombocytopenia: platelet count decreased and thrombocytopenia.^1 
§Febrile neutropenia was reported in 1.8% of patients in the PALBACE® + letrozole group and in no patients in the placebo + letrozole group.^1 
||In the PALBACE^® + letrozole group, 30.2% of patients had Grade 1 alopecia and 2.7% had Grade 2. In the placebo + letrozole group, 14.9% of patients had Grade 1 alopecia and 0.9% had Grade 2.¹

AE, adverse event; ALT, alanine transaminase; CTCAE, Common Terminology Criteria for Adverse Events; LET, letrozole; MedDRA, Medical Dictionary for Regulatory Activities; n, number of patients; PLA, placebo; PT, preferred term.